Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

LLZ 2016-05-31

Ez3D-i / E3

Applicant Ewoosoft Co., Ltd.

K-Number K161246

View Details →

IYO 2016-05-31

Acclarix AX8 Diagnostic Ultrasound System

Applicant Edan Instruments, Inc.

K-Number K161300

View Details →

MMK 2016-05-31

NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six

Applicant North American Rescue, LLC

K-Number K152340

View Details →

JOW 2016-05-31

Cirona 6400

Applicant Devon Medical Products

K-Number K161209

View Details →

OWN 2016-05-31

KARL STORZ Endoscopic ICG Imaging System

Applicant KARL STORZ Endoscopy-America, Inc.

K-Number K152583

View Details →

JAQ 2016-05-31

CT/MR Compatible M.A.C. Interstitial GYN Template

Applicant Mick Radio-Nuclear Instruments, Inc.

K-Number K150979

View Details →

FLL 2016-05-27

Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36

Applicant Sejoy Electronics & Instruments Co., Ltd.

K-Number K153149

View Details →

NJM 2016-05-27

BIJOU Orthodontic Ceramic Bracket

Applicant World Bio Tech Co., Ltd.

K-Number K152167

View Details →

DRT 2016-05-27

Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor

Applicant Ivy Biomedical Systems, Inc.

K-Number K151781

View Details →

FMI 2016-05-27

BD Eclipse Hypodermic Needle

Applicant Becton, Dickinson and Company

K-Number K161170

View Details →

GKL 2016-05-27

Glocyte Automated Cell Counter System

Applicant Advanced Instruments, Inc.

K-Number K152776

View Details →

LBI 2016-05-27

neoBLUE® LED Phototherapy System

Applicant Natus Medical Incorporated

K-Number K160305

View Details →

Page 2586 of 2685

↑